Duns Number:052758618
Device Description: The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and The Vashe Wipes Skin Cleansing Solution Kit contains a bottle of Vashe Wound Solution and dry, nonwoven wipes. The user is instructed to wet the wipes with the Solution just prior to use. The Kit is intended for use in cleansing patient skin.
Catalog Number
00354
Brand Name
Vashe Wipes Skin Cleansing Solution Kit
Version/Model Number
00354
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MAC
Product Code Name
Decontamination Kit
Public Device Record Key
6f4949e7-a450-4ee9-88f7-8dc2ce423726
Public Version Date
May 19, 2020
Public Version Number
5
DI Record Publish Date
March 28, 2018
Package DI Number
10190769003545
Quantity per Package
12
Contains DI Package
00190769003548
Package Discontinue Date
February 01, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 12 |